Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced that its European partner Almirall, S.A. submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for linaclotide, a guanylate cyclase type-C (GC-C) agonist, for the treatment of irritable bowel syndrome with constipation (IBS-C). The submission includes efficacy and safety data from a Phase 3 program comprising two double-blind placebo-controlled trials measured against the endpoints required by the EMA and two open-label long term safety studies. A total of more than 1,600 patients with IBS-C received a once-daily dose of either linaclotide or placebo across the two Phase 3 clinical trials. In these trials, statistically significant improvements in abdominal and bowel symptoms were achieved for linaclotide-treated patients versus placebo-treated patients for the co-primary and secondary endpoints.
Safety data collected across the two Phase 3 IBS-C clinical trials demonstrated that diarrhea was the most commonly reported adverse event and led to study discontinuation in 5 percent of linaclotide-treated patients compared to fewer than 1 percent of patients receiving placebo. Additionally, over 3,200 patients have enrolled in ongoing open-label safety studies and more than 2,000 of those patients have received linaclotide for at least 12 months.
The trials were designed to support regulatory submissions for linaclotide in both Europe and the U.S. In August 2011, Ironwood and its U.S. partner Forest Laboratories, Inc. submitted a New Drug Application for linaclotide to the U.S. Food and Drug Administration.
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